CMS Opens Coverage Discussion for TAVI, Prompting Concerns

Shelley Wood

September 30, 2011

September 29, 2011 (Baltimore, Maryland) - The US Food and Drug Administration (FDA) is still weighing the evidence in favor of approving the first device for transcatheter aortic-valve implantation (TAVI)--with many predicting a positive decision by next month. Late yesterday, the Centers for Medicare & Medicaid (CMS) announced that it had opened a "national coverage analysis" (NCA) for TAVI devices in response to a request from the American College of Cardiology (ACC) and the Society for Thoracic Surgeons (STS).

In July, FDA advisors voted 9 to 0 (with one abstention) that the benefits of the Edwards Sapien transcatheter valve, delivered via the transfemoral route, outweighed its risks in patients who are ineligible for valve surgery, on the basis of the PARTNER trial results. Both the Sapien and the CoreValve (Medtronic) hold CE Mark approval in Europe. The pivotal US CoreValve trial is enrolling around 1500 patients at 41 US centers, with an expected primary completion date of May 2013.

In wording that is already causing alarm bells to ring for investors as well as interventionalists keen to get their hands on the device, the CMS is hinting that coverage of the procedure will be limited to those performed by highly experienced physicians, at designated centers.

Citing the "high stroke and death rates associated with TAVR [transcatheter aortic-valve replacement]" from PARTNER, the CMS says it is "concerned that these adverse events may be more frequent when TAVR is furnished in settings where the physician and/or the facility have limited experience or procedure volume to establish and maintain adequate expertise."

The ACC and STS have long urged a judicious rollout for TAVI devices, and in their request to the CMS, recommended that the CMS require reporting of TAVR procedures in an STS-ACC transcatheter valvular therapy (TVT) registry as one of several conditions of coverage, the CMS announcement states. The ACC/STS request to CMS also stressed that outcomes from TAVI are best when:

  • Treatment decisions are made and the procedure itself is performed by a multidisciplinary team in a specialized heart center.

  • Team members have appropriate training and credentialing (for which requirements are currently under development).

  • The procedure is performed in a hybrid facility that has been specifically modified or built for performing this procedure.

A Slow-Moving Machine

Speaking with heartwire , Society for Cardiac Angiography and Interventions (SCAI) president Dr Christopher White (Ochsner Heart and Vascular Institute in New Orleans, LA) explained that the proposed national coverage determination (NCD) must walk a delicate line. The coverage determination can help make sure that TAVI devices are introduced to the US market safely, but it needs to be finalized swiftly so that all the surgery-ineligible patients who've pinned their hopes on this new technology can afford to get the new procedure.

"I think the NCD wording is appropriate; my concern is that the CMS machine moves very slowly, it's very cumbersome. We had one heck of a coverage-decision nightmare for carotid stenting . . . so [physicians are] concerned that patients will have the same kind of difficulty accessing TAVR that we've had with carotid stenting."

White points out that there will also inevitably be a gap between FDA approval of the Sapien device, which he foresees happening next month, and finalization of the NCD, which he predicts won't happen until the middle of 2012. SCAI has drafted a proposal for local coverage determinations that could help cover reimbursement until the national determination is finalized, he told heartwire .

In the meantime, White says, "I think there will be a lot of cardiologists and patients who will be unhappy with this NCD, because they'll see it as restrictive. From the other side of the coin, it's a noble effort to be on the safe side and to help control this so it's not chaotic in its rollout. This is not like a stent being approved. This is a device that most are not familiar with using, it requires training, and it requires collaboration of surgeons and cardiologists, which is something we don't usually do."

The Market Response

Industry analysts, reading the tea leaves, are predicting what this might mean for uptake of the Edwards Sapien, assuming it's approved. Michael Weinstein from JP Morgan predicted that the CMS will be strict about reimbursing only on-label patients and that only the "best" doctors will perform the procedure on the "worst"--sickest--patients. An expanded label is likely "several years away," Weinstein predicted.

Larry Biegelsen, at Wells Fargo, wrote that the proposed NCD was not as restrictive as some had feared and that both the FDA label, as well as CMS reimbursement, will largely reflect the inclusion and exclusion criteria from the pivotal PARTNER trial.

Edwards' share price fell 11% in reaction to the CMS announcement, "as concerns emerged over the government's eagerness to pay for" the valves, the Wall Street Journal observed. Edwards expects to price its TAVI valve at around $30 000 to $35 000, the paper notes. White told heartwire , however, that the actual cost of the procedure will be at least double that amount.

Edwards has issued a statement about the CMS announcement, calling the proposed NCD "well-written" and poised to ensure "adequate patient access."

The public comment period on the proposed NCD lasts 30 days, closing October 28. "We expect it to evolve as the societies, regulators, and other stakeholders provide their input on the important details," the Edwards statement reads.

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